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Xospata(gilteritinib)
Xospata (gilteritinib) is a small molecule pharmaceutical. Gilteritinib was first approved as Xospata on 2018-11-28. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat myeloid leukemia acute. It is known to target tyrosine-protein kinase receptor UFO, high affinity nerve growth factor receptor, proto-oncogene tyrosine-protein kinase receptor Ret, tyrosine-protein kinase Mer, leukocyte tyrosine kinase receptor, proto-oncogene tyrosine-protein kinase ROS, receptor-type tyrosine-protein kinase FLT3, and ALK tyrosine kinase receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Xospata
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gilteritinib fumarate
Tradename
Company
Number
Date
Products
XOSPATAAstellas PharmaN-211349 RX2018-11-28
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xospataNew Drug Application2019-05-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
Agency Specific
FDA
EMA
Expiration
Code
GILTERITINIB FUMARATE, XOSPATA, ASTELLAS
2025-11-28ODE-222
2023-11-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Gilteritinib Fumarate, Xospata, Astellas
107865002036-07-01DP
89693362031-01-27DS, DP
94874912030-07-28U-2456
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX13: Gilteritinib
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.020156—433
Myelodysplastic syndromesD009190D46121——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8021———2
Myelomonocytic leukemia chronicD015477C93.111———1
Biphenotypic leukemia acuteD015456C95.0—1———1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1———1
Non-small-cell lung carcinomaD00228911———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Hepatic insufficiencyD0485501————1
PharmacokineticsD0105991————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGILTERITINIB
INNgilteritinib
Description
Gilteritinib is a member of the class of pyrazines that is pyrazine-2-carboxamide which is substituted by {3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}nitrilo, (oxan-4-yl)nitrilo and ethyl groups at positions 3,5 and 6, respectively. It is a potent inhibitor of FLT3 and AXL tyrosine kinase receptors (IC50 = 0.29 nM and 0.73 nM, respectively). Approved by the FDA for the treatment of acute myeloid leukemia in patients who have a FLT3 gene mutation. It has a role as an apoptosis inducer, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor and an antineoplastic agent. It is a N-methylpiperazine, a member of piperidines, a secondary amino compound, a monomethoxybenzene, a member of pyrazines, a primary carboxamide, an aromatic amine and a member of oxanes.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCc1nc(C(N)=O)c(Nc2ccc(N3CCC(N4CCN(C)CC4)CC3)c(OC)c2)nc1NC1CCOCC1
Identifiers
PDB—
CAS-ID1254053-43-4
RxCUI2105806
ChEMBL IDCHEMBL3301622
ChEBI ID—
PubChem CID49803313
DrugBankDB12141
UNII ID66D92MGC8M (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
AXL
AXL
NTRK1
NTRK1
RET
RET
MERTK
MERTK
LTK
LTK
ROS1
ROS1
FLT3
FLT3
ALK
ALK
Organism
Homo sapiens
Gene name
AXL
Gene synonyms
UFO
NCBI Gene ID
558
Protein name
tyrosine-protein kinase receptor UFO
Protein synonyms
AXL oncogene, AXL transforming sequence/gene
Uniprot ID
P30530
Mouse ortholog
Axl (26362)
tyrosine-protein kinase receptor UFO (Q80YQ3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,352 documents
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Safety
Black-box Warning
Black-box warning for: Xospata
Adverse Events
Top Adverse Reactions
Mock data
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4,037 adverse events reported
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